Completed

Gemcitabine and Docetaxel in Treating Patients With Recurrent Osteosarcoma (Closed to Accrual as of 12/21/06) or Ewing's Sarcoma or Unresectable or Locally Recurrent Chondrosarcoma

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What is being tested

filgrastim

+ pegfilgrastim
+ docetaxel
Biological
Drug
Genetic
Other
Who is being recruted

Sarcoma

Over 4 Years
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: October 2006

Summary

Principal SponsorSarcoma Alliance for Research through Collaboration
Last updated: March 12, 2012
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2006Actual date on which the first participant was enrolled.

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining gemcitabine with docetaxel may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with docetaxel in treating patients who have recurrent osteosarcoma, recurrent Ewing's sarcoma, or unresectable or locally recurrent chondrosarcoma. OBJECTIVES: Primary * Determine the objective response rate in patients with recurrent osteosarcoma or Ewing's sarcoma or unresectable or locally recurrent chondrosarcoma treated with sequential gemcitabine and docetaxel. Secondary * Determine the time to progression in patients treated with this regimen. * Assess the toxicity of this regimen in these patients. * Compare the pharmacokinetics of this regimen vs gemcitabine alone in these patients. * Obtain tumor samples for cDNA microarray analysis of gene expression and development of cell lines and xenotransplantation models. OUTLINE: This is a nonrandomized, multicenter study. Patients are stratified according to diagnosis recurrent osteosarcoma vs recurrent Ewing's sarcoma vs unresectable or locally recurrent chondrosarcoma). Patients receive gemcitabine intravenously over 90 minutes on days 1 and 8 and docetaxel intravenously over 1 hour on day 8. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 9 and continuing until blood counts recover. Patients may receive pegfilgrastim SC on day 9 (once per course) as an alternative to G-CSF. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Optional blood samples are collected at baseline and periodically during study for pharmacokinetics studies. Optional tumor tissue samples from biopsy or surgical resection are analysed for cDNA microarray analysis of gene expression. Patients are followed every 3 months for 1 year and then every 6 months for 1 year. PROJECTED ACCRUAL: A maximum of 120 patients (40 per stratum) will be accrued for this study within 17-24 months.

Official TitlePhase II Study Of Sequential Gemcitabine Followed By Docetaxel For Recurrent Ewing's Sarcoma, Osteosarcoma, Or Unresectable Or Locally Recurrent Chondrosarcoma [SARC Study] 
Principal SponsorSarcoma Alliance for Research through Collaboration
Last updated: March 12, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
54 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation
: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.

Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 4 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Sarcoma
Criteria

DISEASE CHARACTERISTICS: * Histologically confirmed\* diagnosis of 1 of the following: * Recurrent high-grade osteosarcoma (closed to accrual as of 12/21/06) or Ewing's sarcoma * Progressive disease after standard therapy * Received no more than 2 additional salvage regimens * Chondrosarcoma * Unresectable OR locally recurrent and unable to be completely resected NOTE: \*Biopsy required for isolated pulmonary recurrences * Measurable disease * At least 1 unidimensionally measurable lesion by medical imaging techniques * Ascites, pleural effusions, and bone marrow disease are not considered measurable disease PATIENT CHARACTERISTICS: Age * 4 and over Performance status * ECOG (Eastern Cooperative Oncology Group) 0-2 (≥ 18 years of age) * Karnofsky 50-100% (11-17 years of age) * Lansky 50-100% (≤ 10 years of age) Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 (transfusion independent) * Hemoglobin ≥ 8.0 g/dL (transfusion allowed) Hepatic * Bilirubin ≤ upper limit of normal (ULN) (except for patients with Gilbert's syndrome) * ALT ≤ 2.5 times ULN Renal * Creatinine clearance or radioisotope glomerular filtration rate \> 70 mL/min/1.73 m\^2 OR * Serum creatinine ≤ ULN for age: * Ages 5 and under ≤ 0.8 mg/dL * Ages 6 to 10 ≤ 1.0 mg/dL * Ages 11 to 15 ≤ 1.2 mg/dL * Ages 16 to 18 ≤ 1.5 mg/dL Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study participation * Sensory or motor neuropathy due to prior chemotherapy ≤ grade 1 * Sensory or motor neuropathy due to prior surgery or tumor involvement ≤ grade 2 AND stable or improving * No active or uncontrolled infection * No known hypersensitivity reaction to docetaxel or other polysorbate 80-formulated agents PRIOR CONCURRENT THERAPY: Biologic therapy * At least 72 hours since prior filgrastim (G-CSF) * No prior allogeneic transplantation * No concurrent immunotherapy Chemotherapy * At least 2 weeks since prior myelosuppressive therapy * At least 6 months since prior myeloablative therapy * No prior gemcitabine * No prior taxanes * No other concurrent chemotherapy Endocrine therapy * Concurrent hormonal therapy allowed Radiotherapy * At least 6 weeks since prior local radiotherapy * At least 4 months since prior extensive radiotherapy to more than 50% of the pelvis * At least 4 months since prior cranial spinal radiotherapy * At least 6 months since prior total body irradiation * No concurrent radiotherapy Surgery * No concurrent surgery Other * Recovered from all prior therapy * No other concurrent investigational anticancer therapy


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Patients will be evaluated up to 4 time points(after 2,4,8 and 12 cycles of therapy), each cycle is 21 days. Per RECIST 1.0 and assessed by CT/MRI disease status will be categorized as R=CR/PR(response), F=progressive disease or death(failure), or S(stable disease=neither R nor F) based on the change from baseline. A patient with outcome R or F at any stage is scored as having that overall outcome, a patient with outcome S is re-evaluated after subsequent cycles of therapy. Patients who receive more than 14 cycles of therapy will be scored as the outcome at completion of cycle 14.
Secondary Objectives

Stable disease is measured from the start of the treatment until the criteria for disease progression are met, taking as reference the smallest measurements recorded since the treatment started. The clinical relevance of the duration of stable disease varies for different tumor types and grades. Bayesian statistical model is used. Timepoints for evaluation are post-cycle 2, 4, 8 and 12 using RECIST 1.0 criteria.

Toxicity was graded according to Common Terminology Criteria for Adverse Events v.3.0 (CTCAE v.3.0). For gemcitabine or docetaxel related grade 3 or 4 non-hematological toxicities or hematological toxicities (grade 3 or 4 neutropenia for ≥ 7 days, grade 4 thrombocytopenia, or any platelet transfusion), both agents were withheld until the toxicity was ≤ grade 1. If the toxicity recovered to ≤ grade 1 by cycle day 35, the dose of both agents was reduced for all subsequent cycles. If the toxicity did not resolve by day 35, protocol therapy was discontinued.

Blood samples for the determination of gemcitabine (and its metabolite dFdU) will be obtained prior to infusion, at 75 and 85 minutes (steady state), and 95 105 and 120 minutes, after the start of the 90 minute infusion on day 1 and day 8 of cycle 1. On day 8, docetaxel pharmacokinetics will be performed prior to infusion, 55 minutes (5 minutes prior to the end of infusion), 30 minutes post infusion, 5 hr and 24hr post infusion.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers